Stable prostaglandin-containing compositions

Abstract

A pharmaceutical composition containing a prostaglandin and an alkanoic acid ester of a polyethoxylated sorbitol in an amount effective to enhance the chemical stability of the prostaglandin, and the use thereof for treating ophthalmic conditions. Also disclosed are methods for enhancing the chemical stability of a prostaglandin-containing composition by using an alkanoic acid ester of a polyethoxylated sorbitol.

1. A pharmaceutical composition comprising: 
       
         
           
                 
                 
                 
                 
               
                     
                 
                     
                   travoprost 
                   0.002-0.008% 
                   w/v 
                 
                     
                   polysorbate 80 
                   0.4-0.6% 
                   w/v 
                 
                     
                   benzalkonium chloride 
                   0.010-0.020% 
                   w/v 
                 
                     
                   EDTA 
                   0.05-0.2% 
                   w/v 
                 
                     
                   boric acid 
                   0.1-0.4% 
                   w/v 
                 
                     
                   tromethamine 
                   0.08-0.2% 
                   w/v 
                 
                     
                   mannitol 
                   2.0-8.0% 
                   w/v. 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
       2. A pharmaceutical composition according to  claim 1 , comprising: 
       
         
           
                 
                 
                 
                 
               
                     
                 
                     
                   travoprost 
                   0.004% 
                   w/v 
                 
                     
                   polysorbate 80 
                   0.5% 
                   w/v 
                 
                     
                   benzalkonium chloride 
                   0.015% 
                   w/v 
                 
                     
                   EDTA 
                   0.1% 
                   w/v 
                 
                     
                   boric acid 
                   0.3% 
                   w/v 
                 
                     
                   tromethamine 
                   0.12% 
                   w/v 
                 
                     
                   mannitol 
                   4.6% 
                   w/v. 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
       3. A pharmaceutical composition of  claim 1 , wherein the composition has a pH in the range 5.0 to 7.5. 
     
     
       4. A pharmaceutical composition of  claim 3 , wherein the pH is approximately 6.0. 
     
     
       5. A pharmaceutical composition according to  claim 1  for topical applications. 
     
     
       6. A pharmaceutical composition according to  claim 5  for use in the treatment of ocular hypertension. 
     
     
       7. A pharmaceutical composition according to  claim 5  for use in the treatment of glaucoma.